Specialized Palliative Telemedicine for Patients with Advanced Cancer

NCT05231070 | Completed DMC

• 1 other identifier: R315A18018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Specialized palliative care (SPC) plays an important role in providing patient-centered care and support to informal caregiver, besides establishing/intensifying/coordinating collaboration with primary and secondary health care sectors (hospital nurse/district nurse and general practitioner/oncologist) to improve care and support for patients and burdened informal caregiver. This study proposes to develop a SPC intervention enriched with a dyadic psychological intervention for patients with advanced cancer and their informal caregiver delivered by telemedicine at home (TeleSPC). It is our hypothesis that the intervention can enhance patient-centered care at home, support their informal caregiver, and improve relations/integration between the SPC teams, oncologic teams, the general practitioners and district nurses.

Conditions

Cancer

Keywords

Cancer, telemedicine, dyadic coping, palliative care

Outcome Measures

Primary Outcomes (1)

• Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months

  The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Core 30 (EORTC QLQ-C30) to assess several physical and psychosocial aspects of the patient's health-related quality of life. Scores range from 0 to 100; high values in the functioning and quality of life scales and low values in the symptoms scales indicate better outcomes.

  Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months

Secondary Outcomes (11)

• Change from baseline patients' use of health care system at 6 months

  Baseline and 6 months

• Change from baseline patients and informal caregiver dyadic coping at 4 weeks, 8 weeks, and 6 months

  Baseline, 4 weeks, 8 weeks, and 6 months

• Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months

  Baseline, 4 weeks, 8 weeks, and 6 months

• Change from baseline informal caregiver health related quality of life at 4 weeks, 8 weeks, and 6 months

  Baseline, 4 weeks, 8 weeks, and 6 months

• Healthcare professionals' satisfaction with intervention at 6 months

  6 months

Study Arms (2)

TeleSPC

EXPERIMENTAL

Patients will be offered regular multidisciplinary video consultations with the SPC team and these patients and their informal caregiver will also be offered a dyadic psychological intervention. Regular multidisciplinary video consultations with multidisciplinary team, involvering cooperation between the section og Palliative medicine and the Department of Oncology, District nurse and the general practitioner. Operationel definition of informal caregiver: Patients will designated the closest person involved in their care (e.g., spouse, son/daughter, other relatives, and friends).

Other: TeleSPC

Control

NO INTERVENTION

Patients will follow the current practice in the healthcare system (standard care). Control patients will be offered information to clarify the options available in case of unmet palliative needs. Patients' informal caregiver will be invited to participate in the study, but no intervention will be offered.

Interventions

TeleSPC OTHER

Multidisciplinary video consultations with the SPC team. The team is multiprofessional and composed by physician, nurse, psychologist, social worker, physiotherapist and a chaplain, which is in line with the staffing of most SPC teams in Denmark and abroad. Video consultations will follow the same approach already used in physical consultations at the Section of Palliative Medicine, considering patients' changing needs and providing differentiated treatment and support, with the addition of a psychological intervention for dyadic coping between patient and closest informal caregiver

TeleSPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (at least 18 years old)
• solid organ cancer
• no longer receives curativ treatment
• provide written informed consent
• are able to speak and understand Danish Language
• are cognitively able to participate in the study
• have at least one symptom or problem with score ≥ 3 at the EORTC QLQ-C30

You may not qualify if:

• primary brain cancer or central nervous system metastases
• a prognosis of less than six months
• incapable of cooperating in the trial
• already receive SPC
• adults (at least 18 years old)
• indicated by the patient as the closest informal caregiver
• able to speak and understand danish langues
• provide written informed consent
• \- refuse to participate in the study

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Geana P Kurita, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Randomized controlled trial, in which patients will be randomly assigned either to one of the two arms (1:1): intervention (TeleSPC) or control group (standard care). Assessment will occur at inclusion (baseline) and after 2 weeks, 4 weeks, 8 weeks, and 6 months. sample will be composed by 87 patients in each group and their informal caregiver (1 informal caregiver per patient) .

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: December 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)